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Rosuvastatin and antacids: The effect of a combination antacid preparation containing aluminium hydroxide and magnesium hydroxide on rosuvastatin pharmacokinetics

The effect of a combination antacid preparation containing aluminium hydroxide and magnesium hydroxide on rosuvastatin pharmacokinetics

Clinical Trial

. 2008 Apr;24(4):1231-5.

doi: 10.1185/030079908×280662.

Epub 2008 Mar 19.

Paul D Martin 
1
, Dennis W Schneck, Aaron L Dane, Michael J Warwick

Affiliations

Affiliation

  • PMID:

    18355422

  • DOI:

    10.1185/030079908×280662

Clinical Trial

Paul D Martin et al.

Curr Med Res Opin.

2008 Apr.

. 2008 Apr;24(4):1231-5.

doi: 10.1185/030079908×280662.

Epub 2008 Mar 19.

Authors

Paul D Martin 
1
, Dennis W Schneck, Aaron L Dane, Michael J Warwick

Affiliation

  • PMID:

    18355422

  • DOI:

    10.1185/030079908×280662

Abstract


Objective:

Rosuvastatin, a 3-hydroxy-3-methylglutaryl coenzyme A (HMG-CoA) reductase inhibitor used for the treatment of dyslipidaemia, may be co-administered with antacids in clinical practice. This trial assessed the effect of simultaneous and separated administration of an antacid preparation containing aluminium hydroxide 220 mg/5 mL and magnesium hydroxide 195 mg/5 mL (co-magaldrox 195/220) on the pharmacokinetics of rosuvastatin.


Research design and methods:

A randomised, open-label, three-way crossover trial was performed. Healthy male volunteers (n = 14) received a single dose of rosuvastatin 40 mg alone, rosuvastatin 40 mg plus 20 mL antacid suspension taken simultaneously, and rosuvastatin 40 mg plus 20 mL antacid suspension taken 2 h after rosuvastatin on three separate occasions with a washout of > or = 7 days between each.


Main outcome measures:

The primary parameters were area under the rosuvastatin plasma concentration-time curve from time zero to the last quantifiable concentration (AUC(0-t)) and maximum observed rosuvastatin plasma concentration (C(max)) in the absence and presence of antacid.


Results:

When rosuvastatin and antacid were given simultaneously, the antacid reduced the rosuvastatin AUC(0-t) by 54% (90% confidence interval [CI] for the treatment 0.40-0.53) and C(max) by 50% (90% CI 0.41-0.60). When the antacid was given 2 h after rosuvastatin, the antacid reduced the rosuvastatin AUC(0-t) by 22% (90% CI 0.68-0.90) and the C(max) by 16% (90% CI 0.70-1.01). The effect of repeated antacid administration was not studied and it cannot be discounted that this may have resulted in a stronger interaction than that observed here.


Conclusions:

Simultaneous dosing with rosuvastatin and antacid resulted in a decrease in rosuvastatin systemic exposure of approximately 50%. This effect was mitigated when antacid was administered 2 h after rosuvastatin.

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MeSH terms

Substances

Crestor (Rosuvastatin) – Side Effects, Interactions, Uses, Dosage, Warnings

uses

What is Crestor (Rosuvastatin) used for?

  • Hyperlipidemia
  • Hyperlipoproteinemia Type III (Elevated beta-VLDL + IDL)
  • Homozygous Familial Hypercholesterolemia
  • Hypertriglyceridemia
  • Atherosclerosis
  • Prevention of Cardiovascular Disease
  • Heterozygous Familial Hypercholesterolemia

warnings

What is the most important information I should know about Crestor (Rosuvastatin)?

You should not take rosuvastatin if you are allergic to it, or if you have:

  • liver disease; or
  • if you are pregnant or breast-feeding.

Do not take rosuvastatin if you are pregnant. It could harm the unborn baby. Use effective birth control to prevent pregnancy while you are taking rosuvastatin. Stop taking rosuvastatin and tell your doctor right away if you become pregnant.

Do not breastfeed while you are taking rosuvastatin.

Tell your doctor if you have ever had:

  • liver problems;
  • kidney disease;
  • a thyroid disorder;
  • a habit of drinking more than 2 alcoholic beverages per day;
  • if you are of Asian descent; or
  • if you are 65 or older.

Rosuvastatin can cause the breakdown of muscle tissue, which can lead to kidney failure. This happens more often in women, in older adults, or people who have kidney disease or poorly controlled hypothyroidism (underactive thyroid).

People of Asian descent may absorb rosuvastatin at a higher rate than other people. Make sure your doctor knows if you are Asian. You may need a lower than normal starting dose.

User Reviews & Rating

Overall rating for Crestor (Rosuvastatin)

2.6

out of  5

Side Effects

Easy to Use

Effectiveness

Read Crestor (Rosuvastatin) Reviews

Side Effects

What are the side effects of Crestor (Rosuvastatin)?

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

  • unexplained muscle pain, tenderness, or weakness;
  • muscle weakness in your hips, shoulders, neck, and back;
  • trouble lifting your arms, trouble climbing or standing;
  • confusion, memory problems; or
  • liver problems–upper stomach pain, tiredness, loss of appetite, dark urine, jaundice (yellowing of the skin or eyes).

Common side effects may include:

  • headache;
  • weakness;
  • muscle aches; or
  • nausea, stomach pain.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Pregnancy & Breastfeeding

Can I take Crestor (Rosuvastatin) if I’m pregnant or breastfeeding?

Contraindicated in pregnancy

Based on FDA pregnancy categories

Do not take rosuvastatin if you are pregnant. It could harm the unborn baby. Use effective birth control to prevent pregnancy while you are taking rosuvastatin. Stop taking rosuvastatin and tell your doctor right away if you become pregnant.

Do not breastfeed while you are taking rosuvastatin.

Interactions

What drugs and food should I avoid while taking Crestor (Rosuvastatin)?

Avoid eating foods high in fat or cholesterol, or rosuvastatin will not be as effective.

Avoid drinking alcohol. It can raise triglyceride levels and may increase your risk of liver damage.

Some antacids can make it harder for your body to absorb rosuvastatin. Avoid taking an antacid that contains aluminum or magnesium within 2 hours after taking rosuvastatin.

Dosage Guidelines & Tips

How to take Crestor (Rosuvastatin)?

Use Crestor (Rosuvastatin) exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended.

What should I do if I missed a dose of Crestor (Rosuvastatin)?

Take the medicine as soon as you can, but skip the missed dose if you are more than 12 hours late for the dose. Do not use two doses at one time.

Overdose Signs

What happens if I overdose on Crestor (Rosuvastatin)?

If you think you or someone else may have overdosed on: Crestor (Rosuvastatin),  call your doctor or the Poison Control center

(800) 222-1222

If someone collapses or isn’t breathing after taking Crestor (Rosuvastatin), call 911

911

What to Expect

Rosuvastatin starts to lower cholesterol levels within about a week, but it may take up to a month before it works completely.

You may have to stay on rosuvastatin for the rest of your life. You’ll only experience the benefits while you take this medicine. Your cholesterol levels may go back up if you stop using rosuvastatin.

Secondary Uses

Statins, including rosuvastatin, have been studied or used to treat other medical conditions that they aren’t FDA-approved for. For example, rosuvastatin is sometimes given to patients after a heart or kidney transplant to improve outcomes.

Images

CRESTOR 10

Color: pink

Shape: round

Form: film coated

Imprint: CRESTOR 10

CRESTOR 20

Color: pink

Shape: round

Form: film coated

Imprint: CRESTOR 20

CRESTOR, 40

Color: pink

Shape: oval

Form: film coated

Imprint: CRESTOR, 40

Rosuvastatin: instruction, price, analogues | Biofarm

film-coated tablets (Rosuvastatin)

Manufacturer:

Biofarm

Composition and form of release

You can pay for medicines with a card pidtrimka

Classification

Atherosclerosis of the aorta

ICD I70. 0

Atherosclerosis of the arteries of the extremities

ICD I70.2

Atherosclerotic heart disease

ICD I25.1

Hypertensive heart disease without (congestive) heart failure

ICD I11.9

Hypertension (AH) with heart disease and heart failure (HF)

ICD I11.0
Other specified lesions of cerebral vessels ICD I67.8

Other forms of angina pectoris

ICD I20.8
Cerebral infarction caused by thrombosis of the cerebral arteries ICD I63.3

Post-infarction coronary heart disease (CHD), (past myocardial infarction)

ICD I25.2

Ischemic heart disease with hypertension (CHD with HT)

ICD I25. 9

Ischemic heart disease with angina pectoris

ICD I25.0

Unstable angina

Manual of cardiology (ed. V.N. Kovalenko, 2008) … Clinical protocol for the provision of medical care to patients with acute coronary syndrome without ST segment elevation (MI without Q wave and unstable angina pectoris)
Manual of Cardiology (ed. V.N. Kovalenko, 2008) … Acute coronary syndrome without persistent ST segment elevation

ICD I20.0

Acute transmural (with Q wave) infarction of the inferior myocardial wall

Manual of cardiology (ed. V.N. Kovalenko, 2008) … Clinical protocol for the provision of medical care to patients with acute coronary syndrome with ST segment elevation (MI with Q wave)
Manual of cardiology (ed. V.N. Kovalenko, 2008) … Acute myocardial infarction

ICD I21. 1

Acute transmural infarction of the anterior myocardial wall

Manual of cardiology (ed. V.N. Kovalenko, 2008) … Clinical protocol for the provision of medical care to patients with acute coronary syndrome without ST segment elevation (MI without Q wave and unstable angina pectoris)
Manual of cardiology (ed. V.N. Kovalenko, 2008) … Acute myocardial infarction
Manual of Cardiology (ed. V.N. Kovalenko, 2008) … Acute coronary syndrome without persistent ST segment elevation

ICD I21.0

Persistent atrial fibrillation

Manual of cardiology (edited by V.N. Kovalenko, 2008) … Clinical protocol for providing medical care to patients with atrial fibrillation (flutter)
Manual of cardiology (ed. V.N. Kovalenko, 2008) … Diagnosis and treatment of atrial fibrillation

ICD I48.1

Recurrent myocardial infarction, unspecified

Manual of cardiology (ed. V.N. Kovalenko, 2008) … Clinical protocol for the provision of medical care to patients with acute coronary syndrome without ST segment elevation (MI without Q wave and unstable angina pectoris)
Manual of cardiology (ed. V.N. Kovalenko, 2008) … Acute myocardial infarction
Manual of Cardiology (ed. V.N. Kovalenko, 2008) … Acute coronary syndrome without persistent ST segment elevation

ICD I22.9
Consequences of cerebral infarction ICD I69.3

Angina

ICD I20.9

Juvenile arterial hypertension

ICD I10

Date added: 07/05/2023

© Compendium 2019

Recommended analogues of Rosuvastatin:

Klivas 10

film-coated tablets 10 mg blister No. 10, 30, 90

Acino

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Klivas 20

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Acino

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Crestor

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9000 2 AstraZeneca

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Gedeon Richter

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Mertenil

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Gedeon Richter

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Gledpharm Ltd

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Ozalex ®

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90 002 Gladpharm Ltd

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Preventer

90

Darnitsa

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Preventor

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Darnitsa

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Rovamed

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Medochemie Ltd

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Rozart

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Teva Ukraine

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Rosart

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Rosart

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Teva Ukraine

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Rosart

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Teva Ukraine

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Rozastin

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Micro Labs

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Rozastin

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Micro Labs

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Rosvator

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SUN

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SUN

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Rosister

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Rosister

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Kiev Vitamin Plant

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InterChem

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Rosuvastatin IC

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InterChem

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Rosuvastatin IC

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Roxera ®

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KRKA d.d. Novo Mesto

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Roxera ®

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Romestin® 10

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Farmak

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5 herbs and spices that can reduce the effect of drugs

  • Health

Many seemingly harmless herbs and herbal preparations can interact with various drugs and reduce their effect. So, when prescribing dietary supplements for yourself, you should be very careful.

March 4, 20231

Source:
iStockphoto

We know about the health benefits of garlic and green tea, both recognized as powerful antioxidants. It is very useful to use them in the diet in moderation, but it can be unsafe to get involved in preparations based on them. And not only them. There are other herbs and spices that seriously affect the effectiveness of the pharmaceutical preparations you take, writes ProNews.

Turmeric

This spice and dietary supplements with curcumin are often called “fool’s gold”. Science considers its antitumor, anti-inflammatory and antibacterial properties to be only potential. But the interaction of curcumin with drugs can even be dangerous.

There is evidence that curcumin may reduce the effect of many antidepressants and neuroleptics. It is also known to interact with anticoagulants, antacids, drugs to control blood pressure.

– Whole turmeric, turmeric extract or pure curcumin are credited with at least 175 different beneficial physiological effects and more than 600 different indications, explains renowned physician, toxicologist Alexei Vodovozov. “But if you search the available databases for relevant studies, it turns out that of them are at the preclinical stage, , that is, cell cultures and laboratory animals (mice and rats). And the results found are of interest mainly to mice and rats, because they are transferred to humans very, very rarely.

Read also

Garlic

Garlic extract can reduce the concentration of cardiac glycosides, glucocorticoids – drugs that transport P-glycoprotein protein across the cell membrane – such as colchicine, quinidine, desloratadine, digoxin, rosuvastatin and others , writes ProNews

Garlic extract can also thin the blood like aspirin, which can be a problem if you are taking blood thinners.

– It happens that people take both aspirin and anticoagulants, then the risk of bleeding increases exponentially. I have had such cases. People go to the hospital to the surgeons on the operating table, because they have gastrointestinal bleeding, , doctor Boris Shelyapin told Doctor Peter earlier.

Green tea

Everyone knows about the benefits of green tea – it has antioxidant properties, anti-inflammatory, promotes the expansion of cerebral vessels, improves its nutrition, oxygen supply. All this is true, if you drink 2-3 cups of quality green tea a day. Although it is not shown to everyone – after all, a drink can lower blood pressure and harm ulcers.

Taking green tea extract as a dietary supplement can also be hazardous to health. There is evidence that green tea extract may reduce the effectiveness of some statins and some beta-blockers used to treat hypertension. Also concentrated green tea supplements may interact with some vasoconstrictors.

Thistle or milk thistle

This plant is believed to have many beneficial properties, and the active substance silymarin contained in it is called the first “protector” of the liver.